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Antigen-detecting Rapid Diagnostics Tests (RDT) [(Ag-RDT)] that are comprised of a plastic cassette with sample and buffer wells, a nitrocellulose matrix strip, with a test line with bound antibody specific for conjugated target antigen-antibody complexes and a control line with bound antibody specific for conjugated-antibody. In the case of SARS-CoV-2 RDTs the target analyte is often the virus’ nucleocapsid protein, preferred because of its relative abundance.
Typically, all materials that are required to perform the test, including sample collection materials, are provided in the kit, with the exception of a timer. After collecting the respiratory specimen and applying it to the test strip, results are read by the operator within 10 to 30 minutes with or without the aid of a reader instrument.
The use of a reader standardizes interpretation of test results, reducing variance in assay interpretation by different operators, but requires ancillary equipment. Most of the currently manufactured tests require nasal or nasopharyngeal swab samples, but companies are carrying out studies to assess the performance of their tests using alternative sample types such as saliva, oral fluid and sample collection systems to potentially expand options for use and to facilitate safe and efficient testing.
Generally, the ease-of-use and rapid turnaround time of Ag-RDTs offers the potential to expand access to testing and decrease delays in diagnosis by shifting to decentralize testing of patients with early symptoms. The trade-off for simplicity of operation of Ag-RDTs is a decrease in sensitivity compared to NAAT.
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